This invention relates to an intra-labia urinary collection device designed to obtain a "clean-catch" urinary sample free from contamination by bacteria or cells from the vagina.
Urinary tract infections are the second leading cause of physician visits in the United States. A urinary infection is typically caused by bacteria entering the discharge end of the urinary tract (the urethral opening) and traveling up the uretha (which carries urine from the bladder to outside the body). Women are more susceptible to the infection than men because their urethras are only about 1.5 inches long, compared with 8 or 9 inches in men. Furthermore, women's urethral openings are near anal and vaginal sources of infectious agents.
Diagnosing a urinary tract infection depends on analysis and culture of a "clean-catch" urine sample. A "clean-catch" specimen requires collecting the urine at midstream, since the first bit of urine may be contaminated with bacteria that has migrated into the urethra from the outside.
In a typical prior art procedure, a patient first wipes off the exterior genitalia, urinates a little into a toilet or bedpan and then, without interrupting the flow, urinates about an ounce more into a collection vial, finishing urinating into the toilet or bedpan if necessary. There is nothing to prevent contamination of the sample by bacteria or cells from the vagina or anus if the genital area has not been sufficiently cleaned, if there is a vaginal discharge after cleaning, or if urine enters the vagina during discharge.
The alternative to a simple vial collection has typically been a catheter inserted up the urethra and into the bladder. This may be painful and at least uncomfortable and many women greatly dislike this procedure.
There has thus long been a need for an external female urinary collection device for obtaining a clean-catch specimen for use in diagnosing a urinary tract infection. The device should ensure that the sample contains urine uncontaminated by fluids, bacteria or epithelial cells from either the vagina or anus. It is an object of this invention to provide such a device.
Another object of this invention is to provide an intra-labia urinary collection device for use by ambulatory or bedridden females who have the need to control or direct urine discharges when it is impractical or impossible to use a common urinal. Such persons must typically void urine in a supine position and it is desired that the urine drain easily and comfortably into the device with minimal if any leakage or spillage.